BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Confocal Microprobe Imaging System

    DI: 06971679949782 · Model: BrightP980 · Wuxi Hisky Medical Technologies Co.,Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Confocal Microprobe Imaging System
    Primary DI
    06971679949782
    Version / Model
    BrightP980
    Company Name
    Wuxi Hisky Medical Technologies Co.,Ltd.
    Labeler DUNS
    544348534
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-08-14
    Public Version
    3
    Public Version Date
    2025-12-29
    Public Version Status
    Update
    Public Device Record Key
    902711e1-9aee-4c64-bbdd-a66338f675bb

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Liquid Chemical

    Product Codes

    Code Name
    OWN Confocal Optical Imaging

    GMDN Terms

    Code Name
    62287 Confocal endomicroscopy system

    Identifiers

    Type ID
    Primary 06971679949782